General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
NCT Number: NCT04556357
The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Yinchuan, Ningxia, 750004, China
Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. But the efficacy and safety in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Criteria: Inclusion Criteria:
Exclusion criteria
A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block
Other names: Vasopressors
A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block
Other names: Vasopressors
Time frame: 1-15 minutes after spinal anesthesia.
Heart rate < 60 beats/min
Time frame: 1-15 minutes after spinal anesthesia
Evaluated by performance error (PE)
Time frame: 1-15 minutes after spinal anesthesia
Evaluated by performance error (PE)
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) < 80% of the baseline
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) < 60% of the baseline
Time frame: 1-15 minutes after spinal anesthesia
Presence of nausea and vomiting in patients after spinal anesthesia
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) >120% of the baseline.
Time frame: Immediately after delivery
From umbilical arterial blood gases.
Time frame: Immediately after delivery
From umbilical arterial blood gases.
Time frame: Immediately after delivery
From umbilical arterial blood gases.
Time frame: 1 min after delivery
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time frame: 5 min after delivery
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
General Hospital of Ningxia Medical University
Other
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Controlled Trial
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